Sarah Cartmell, Professor of Bioengineering, The University of Manchester – Written evidence (INQ0054)
- Sophisticated biomaterials are used as carriers for advanced treatments such as regenerative medicine, cell and gene therapies, many of which will be essential in the Government’s mission to extend the healthy and independent lives by five years.
- We are fortunate that the UK, with its world-class academic base, is at the forefront of the basic science research in this field led by the likes of the Henry Royce Institute.
- The final global roll-out is best done by a large corporate entity, who enjoy innovation not by carrying it out but by acquiring it after it has been thoroughly tested by someone else.
- We can learn from other countries, such as South Korea, Japan and California, who manage the transition from academia to industry more effectively and more efficiently.
- A revision of regulatory policy would place the UK in an advantageous position that offers a safe and rigorous but intuitive and streamlined process.
- I am the Head of the Department of Materials at The University of Manchester and the UK Biomedical Materials champion for The Royce Institute of a £235million UK government investment for advanced materials.
- My response covers feedback on technologies that can improve health and wellbeing in old age, opportunities for the UK to commercialise discoveries and innovations relating to healthier ageing, and the policy implications of a healthier older population.
Technologies that can improve health and wellbeing in old age
- We live in an exciting time where new technological treatments will help extend healthy, independent lives: many of these technologies will act on or inside the body in new and innovative ways.
- One of the new excitements arises from the fact that the fabric out of which these technologies are manufactured can now be more than an inert, protective coating or carrier, but can be designed to have biological activity in themselves. These are new modern biomaterials.
- For instance, bone graft substitutes used to treat (or even help prevent) osteoporotic, fragility fractures are able not only to promote new bone tissue but also stimulate the local blood supply (angiogenesis) as well as being innately anti-microbial and able to fight infection. These sophisticated biomaterials are used as carriers for advanced treatments such as regenerative medicine, cell and gene therapies, many of which will be essential in the Government’s mission to extend the healthy and independent lives by five years.
Opportunities for the UK to commercialise discoveries and innovations relating to healthier ageing
- Globally the biomaterials market is worth $70 billion (2016) and is growing fast, 14.5% CAGR (Markets and Markets ™ 2019)1, reaching $149 billion in 2021. Much of this growth will be in treatment areas that are critical in the care of the elderly, such as orthopaedics and neurology (Mordor Intelligence 2019)2.
- We are fortunate that the UK, with its world-class academic base (World University Rankings, Times Higher Education 2019)3, is at the forefront of the basic science research in this field led by the likes of the Henry Royce Institute. This gives this country an advantage in terms of harnessing these new biomaterials technologies.
- There have been some excellent stimuli to help and encourage the commercial uptake of these new technologies, such as the Enterprise Investment Scheme (EIS) and the Seed Enterprise Investment Scheme (SEIS) schemes and the funding streams from the likes of Innovate UK and other fiscal and private financial stimuli (Life Sciences Industrial Strategy 2017)4, as well as the charity sector (Association of Medical Research Charities 2019)5.
- However, if one takes an overview of the process from the basic science laboratory to global clinical dissemination of a new biomaterial-based treatment, there are still areas that can be improved. The final global roll-out is best done by a large corporate entity, who enjoy innovation not by carrying it out but by acquiring it after it has been thoroughly tested by someone else.
- It has been estimated by some market reports that the bulk, some 80%, of the early development work in the UK is done by small and medium enterprises (SMEs) (National Federation of Self Employed & Small Businesses 2019, Association of British HealthTech Industries 2019)6 and there are several examples for successes from this approach.
- However, in this country we can learn from others, such as South Korea, Japan and California, who manage the transition from academia to industry more effectively and more efficiently (Reuters: Innovative Universities 2018)7.
- The Henry Royce Institute is pioneering an approach in which the scientists carry out their early work in a way that will later seamlessly feed into future regulatory submission. They either do this themselves or they are directly supported by experts in this field. This relieves some of the future burdens on the SME, who today often have to repeat this type of work at great expense and time. This redundant activity is especially burdensome to a small enterprise.
- It can be seen from some of the most innovative Universities outside the UK8 that having the scientists and technologists with a good understanding of the full process from early discovery through to the commercial sector and regulations means that the time and cost to market is reduced. In this way the Henry Royce Institute believes it will accelerate the time to get new biomaterials to market, while increasing the success rate of getting these into the clinic to support new treatments and helping to extend healthy and independent lives of the ageing population.
The policy implications of a healthier older population
- Current regulatory policy is not fit for purpose where new technology can offer better (more relevant information) and cheaper options than moving from animal model straight into first in-man clinical trials. Options such as testing new products on ex vivo perfusion systems (where ethically consented human organs such as the heart or lungs (that are not suitable for donation but suitable for research) are kept viable in the laboratory for a period of time by perfusing with blood), organ on a chip (where a high throughput series of human cell 3D clusters are grown on a polymer chip), tissue engineered human toxicology constructs (where larger engineered samples of human tissue can be cultured in the lab and exposed to new biomedical materials or pharmaceutical drugs for efficacy and safety testing) can give go/no-go information that often is only discovered at human clinical trial stage. This is because of the difference between animal (eg mouse/rabbit) and human pathology.
- These new approaches will be able to test for human tissue response before clinical trial. Although this would be an additional step to testing before clinical trial, this will offer new information only gained from testing on human tissues and will prevent a lot of unnecessary clinical trials.
- In addition, a revision of regulatory policy would place the UK in an advantageous position that offers a safe and rigorous but intuitive and streamlined process that will place the UK as a favourable country to translate new products for global companies due to a safe but quicker and easier system.
- www.marketsandmarkets.com/Market-Reports/biomaterials-393.html - full report commercially confidential
- www.mordorintelligence.com/industry-reports/biomaterials-market - full report commercially confidential
- Bell J (2017) Life Sciences Industrial Strategy – A report to the Government from the life sciences sector. Office for Life Sciences
- Making a difference: Impact Report 2019 (2019) Association of Medical Research Charities www.amrc.org.uk/making-a-difference-impact-report-2019
20 September 2019